MAUDE Adverse Event Report: AMO PUERTO RICO MFG. INC. TECNIS SIMPLICITY; EXTENDED DEPTH OF FOCUS INTRAOCULAR LENS

Model Number	DXR00V
Medical Device Problem Codes	Break (1069); Material Split, Cut or Torn (4008)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	06/27/2024
Type of Reportable Event	Malfunction
Event or Problem Description
It was reported that the preloaded johnson and johnson (jnj) intraocular lens (iol) came out damaged and in 2 pieces when being deployed for implant.The iol was not implanted because the physician noticed the issue under a microscope as he was advancing it.Both the injector and lens came in contact with the patient¿s right eye but was not implanted.The procedure was completed with a backup jnj lens.There were no complications such as a capsule tear, vitrectomy, or sutures.No further information was provided.
Additional Manufacturer Narrative
Section a3b, gender: the customer responded "f".Section a4, patient weight: information unknown/not provided.Section d6a, if implanted, give date: not applicable.There is no indication the lens was implanted.Section d6b, if explanted, give date: not applicable.There is no indication the lens was implanted.Therefore, not explanted.Section h3, device evaluated by manufacturer: the device has not been returned for evaluation.Therefore, a failure analysis of the complaint device cannot be completed.A review of the device history record, complaint trending, and risk documentation for this device will be performed.Upon completion of the review, if there is any further relevant information a supplemental medwatch will be filed.Attempts have been made to obtain the missing information.However, to date, it has not been received.All pertinent information available to johnson & johnson surgical vision, inc.Has been submitted.
Additional Manufacturer Narrative
Additional information.Section d9: device available for evaluation? yes.Section d9: date returned to manufacturer: jul 16, 2024.Section h3: evaluated by manufacturer: yes.Device evaluation: the device was inspected under magnification.The complaint device presented with the plunger rod partially advanced and overriding a lens that was stuck in the cartridge.Viscoelastic residue was distributed through the entire length of the cartridge.The lens module was inspected and presented with no damage or viscoelastic residue.The device assembly was inspected and presented with no issues.The plunger rod advancement was inspected, and no resistance was felt.The lens was removed from the cartridge and cleaned.The lens was torn and damaged.Based on the complaint investigation results, the product was released within specifications.Conclusion: as a result of the investigation there is no indication of a product quality deficiency, and the reported issue could not be verified.All pertinent information available to johnson & johnson surgical vision, inc.Has been submitted.

• Brand Name: TECNIS SIMPLICITY
• Common Device Name: EXTENDED DEPTH OF FOCUS INTRAOCULAR LENS
• Manufacturer (Section D): AMO PUERTO RICO MFG. INC.; road 402 north, anasco ind. pk; anasco PR 00610
• Manufacturer Contact: somyata nagpal ; 31 technology drive; irvine, CA 92618 ; 7142478552
• MDR Report Key: 19677324
• Report Number: 3012236936-2024-000189
• Device Sequence Number: 20574225
• Product Code: POE
• UDI-Device Identifier: 05050474761698
• UDI-Public: (01)05050474761698(17)250407
• Combination Product (Y/N): N
• Initial Reporter State: MI
• Initial Reporter Country: US
• PMA/510(K) Number: P980040
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Serviced by Third Party (Y/N): Unknown
• Reporter Type: Manufacturer
• Report Source: Health Professional,User Facility
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date (Section B): 08/05/2024

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Operator of Device: Health Professional
• Device Expiration Date: 04/07/2025
• Device Model Number: DXR00V
• Device Catalogue Number: DXR00VU150
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Is the Reporter a Health Professional?: Yes
• Was the Report Sent to FDA?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 06/28/2024
• Supplement Date Received by Manufacturer: 07/29/2024
• Initial Report FDA Received Date: 07/04/2024
• Supplement Report FDA Received Date: 08/06/2024
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 04/07/2022
• Is the Device Labeled for Single Use? (Y/N): Yes
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Usage of Device: Initial
• Patient Sequence Number: 1
• Patient Age: 64 YR
• Patient Sex: Female
• Patient Ethnicity: Non Hispanic
• Patient Race: White